COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages

Public health emergency response and other updates from FDA since our last MCMi email include:

• August 16, 2022: FDA Roundup including a new web page to highlight Operation Lascar, which, with the United Kingdom, is the FDA’s first bilateral initiative focused on the movement of illicit FDA-regulated products
• August 16, 2022: Monkeypox response: The Jynneos vaccine EUA fact sheet for recipients and caregivers is now available in additional languages 
• August 12, 2022: FDA Roundup including a safety communication advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test
• August 12, 2022: Monkeypox response: Information for Blood Establishments Regarding the Monkeypox Virus and Blood Donation
• August 11, 2022: FDA Safety Communication: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative
• August 10, 2022: Monkeypox response: Dear Healthcare Provider letter (PDF), accompanying the EUA for Jynneos

Quick links: COVID-19 updates from FDA, FDA Monkeypox Response 

FDA posted a safety communication to provide information to blood establishments regarding monkeypox virus and blood donations. Worldwide, there have been no reports of transmission of monkeypox virus through blood transfusion and the risk of transfusion-transmission remains theoretical. The communication explains that existing safeguards for blood safety are likely to identify individuals who present to donate who are diagnosed with monkeypox virus or who are currently at the greatest risk for infection with monkeypox virus. Further, the FDA will continue to monitor cases of monkeypox in the U.S. and worldwide and the available information about potential risk of transfusion-transmitted monkeypox virus. The FDA will provide additional information as it becomes available. (August 12, 2022)

Jynneos vaccine EUA fact sheet translations

On August 9, 2022, FDA issued an EUA for the Jynneos vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection. The EUA fact sheet for recipients and caregivers is now available in additional languages. (August 16, 2022)

EUA fact sheet: Fact Sheet for Recipients and Caregivers about Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-Replicating) (English)

• 中文 (Chinese, Simplified)
• 한국어 (Korean)
• Español (Spanish)
• Tagalog (Tagalog)
• Tiếng Việt (Vietnamese)

FDA is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms. (August 11, 2022)

In vitro diagnostic (test) EUAs

As of August 16, 2022, 439 tests and sample collection devices are authorized by FDA under EUAs. These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,084 revisions to test EUAs. Also see: COVID-19 Test Basics  

Resources to keep yourself and others safe from COVID-19
Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.)

Expiration date extensions of COVID-19 at-home tests
Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.  

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.